Pain Clinical Trial
— ADEOfficial title:
Placebo Effect in Children With Attention Deficit Disorder and/or Hyperactivity Disorder
In Quebec, there has been an important increase of Attention Deficit Hyperactivity Disorder (ADHD) diagnosis since 2015. ADHD symptoms, related to behavioural and/or concentration difficulties, are very similar to other disorders symptoms, such as anxiety and depression, and have a significant impact on students' academic success and future life. Adults (parent, teacher, coach) expectations towards a child's abilities are consciously or unconsciously perceived by the child, influence his expectations of his own abilities, and thus his academic performance (Pygmalion effect). The child and his entourage's expectations are therefore a major factor to consider, especially in school-age children. According to ADHD studies, some brain areas involved in pain regulation and in attention cognitive abilities develop at a slower rate in children with ADHD than the other children. Considering the deleterious consequences generated by the symptoms of this disorder, the research project aims to better understand the role of expectations in children with ADHD in a medical (pain) and school (attention abilities) context. It also aims to contribute to better understand the role of the brain on the expectations effect and ADHD. In this study, children expectations will be modulated while pain experiments and cognitive task will be realized by children with and without ADHD. Brain measures will also be assessed with advanced techniques. Thus, we hope that the results will help improve intervention strategies in these contexts to ensure better support for children with ADHD, with a distant goal of contributing to the development of stronger tools for differential diagnostics.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | June 30, 2023 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 9 Years |
Eligibility | Inclusion Criteria: - Child 8 or 9 years old - ADHD diagnosis confirmed by a qualified health professional (for the ADHD group only). - Understand French Exclusion Criteria: - Other neurological problems other than ADHD - Diagnosis of a psychological disorder - Intellectual disability |
Country | Name | City | State |
---|---|---|---|
Canada | Centre de recherche sur le vieillissement (CdRV) | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke |
Canada,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Placebo and nocebo effect on pain | Pain (thermal) will be generated using an experimental pain paradigm using a thermode (heat). Perceived pain level will be assessed using a standardized tool; a computer-connected Visual Analogue Scale (VAS). The participant can score the pain sensation with a 0 to 10 scale, where 0 means "no pain" and 10 "the most intense pain tolerable". | Change from pre-test pain sensation to the pain sensation after the two "medications" (collected in one visit in March-April during the pre-test, after the placebo and after the nocebo. Data will be reported within the following 6 months. | |
Primary | Placebo and nocebo effect on attention abilities | Attention abilities will be assessed using equivalent randomly assigned attentional tasks, the Stop signal task (SST). The measured outcomes are the reaction times in milisecond (ms) and the proportion of correct/incorrect reactions. | Change from pre-test results to the results observed after the two "medications" (collected in one visit in March-April during the pre-test, after the placebo and after the nocebo. Data will be reported within the following 6 months. | |
Secondary | Neuroanatomical measures : DLPFC gray matter volume | The neuroanatomy measurements will be assessed using magnetic resonance imaging (MRI). Structural MRI will be used to measure the DLPFC anatomy. | The outcome measure should be assessed during the visit 2, which should occur in 3-4 months. Data should be reported within the following 6 months. | |
Secondary | Neuroanatomical measures : DLPFC neural activity | The neuroanatomy measurements will be assessed using magnetic resonance imaging (MRI). Fonctionnal MRI will be used to measure the DLPFC neural activity. | The outcome measure should be assessed during the visit 2, which should occur in 3-4 months. Data should be reported within the following 6 months. | |
Secondary | Neuroanatomical measures : DLPFC neural connection | The neuroanatomy measurements will be assessed using magnetic resonance imaging (MRI).
Diffusion MRI will be used to measure the DLPFC neural pathways. |
The outcome measure should be assessed during the visit 2, which should occur in 3-4 months. Data should be reported within the following 6 months. | |
Secondary | Neuroanatomical measures : DLPFC vascularisation | The neuroanatomy measurements will be assessed using magnetic resonance imaging (MRI). Vascular MRI will be used to measure the DLPFC vascular network. | The outcome measure should be assessed during the visit 2, which should occur in 3-4 months. Data should be reported within the following 6 months. | |
Secondary | Neurophysiological measures: inhibitory mechanisms | The inhibitory mechanisms will be evaluated using transcranial magnetic stimulation (TMS) using the short intracortical interval inhibition measurement technique (short inhibition intracortical interval, SICI), were magnetic pulses are applied to the motor cortex. This method requires a double stimulation at an interval of 1 to 6 ms so that the muscle response usually observed is inhibited. | The outcome measure should be assessed during the visit 2, which should occur in 3-4 months. Data should be reported within the following 6 months. | |
Secondary | Heart rate measures | Heart rate measures will be collected with an electrocardiogram (using 3 electrodes in the back). | Change from pre-test results and to the results observed after the two "medications" (collected continuously in visit 1 in March-April during the pre-tests, after the placebo and after the nocebo. Data will be reported within the following 6 months. | |
Secondary | ADHD symptoms | More information about the ADHD related symptoms and impacts will be collected by questionnaires for the parent. | Assessment during visit 1 in March-April. Data will be reported within the following 6 months. | |
Secondary | Pain catastrophizing | This data will be collected with the Pain Catastrophizing Scale for Children in French (PCS-C-FR). Scale from 0 to 52, where 0 is better and 52 is worse. | Assessment during visit 1 in March-April. Data will be reported within the following 6 months. | |
Secondary | Anxiety traits | This data will be collected with the State-Trait Anxiety Inventory for Children (STAI-CH) | Assessment during visit 1 in March-April. Data will be reported within the following 6 months. | |
Secondary | Sleep quality - Child | This data will be collected with the Morningness-Eveningness for Children Scale in French. | Assessment during visit 1 in March-April. Data will be reported within the following 6 months. | |
Secondary | Sleep quality - Parent | This data will be collected with the Pediatric Sleep Questionnaire in French (parent). | Assessment during visit 1 in March-April. Data will be reported within the following 6 months. | |
Secondary | Sociodemographic measures | This data will be collected with an adapted version of the the Canadian ADHD Ressource Alliance (CADDRA) questionnaire. | Assessment during visit 1 in March-April. Data will be reported within the following 6 months. |
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